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FDA 510(k)

POLAR CATH PERIPHERAL DILATATION SYSTEM

K-Number: K051916 · 2005-08-05

ApplicantCryo Vascular Systems, Inc.
Decision Date2005-08-05
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLAR CATH PERIPHERAL DILATATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cryo Vascular Systems, Inc.. It received FDA 510(k) clearance on 2005-08-05 under 510(k) number K051916. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLAR CATH PERIPHERAL DILATATION SYSTEM?

POLAR CATH PERIPHERAL DILATATION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-05. The listed applicant is Cryo Vascular Systems, Inc.. The 510(k) number is K051916.

When did POLAR CATH PERIPHERAL DILATATION SYSTEM receive FDA 510(k) clearance?

POLAR CATH PERIPHERAL DILATATION SYSTEM received FDA 510(k) clearance on 2005-08-05, under 510(k) number K051916.

Who is the listed applicant for POLAR CATH PERIPHERAL DILATATION SYSTEM?

The FDA 510(k) record lists Cryo Vascular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLAR CATH PERIPHERAL DILATATION SYSTEM?

The FDA product code for POLAR CATH PERIPHERAL DILATATION SYSTEM is LIT.

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Other records listing Cryo Vascular Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K042230POLARCATH PERIPHERAL BALLOON CATHETER SYSTEMK042541MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEMK033622POLARCATH PERIPHERAL DILATATION SYSTEMK030742POLARCATH PERIPHERAL BALLOON CATHETER SYSTEMK023463CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNITK022061CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER

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Related Devices (Code: LIT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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